Baclofen and acamprosate based therapy of neurological disorders

Abstract

The present invention relates to combinations and methods for the treatment of neurological disorders related to glutamate excitotoxicity and Amyloid β toxicity. More specifically, the present invention relates to novel combinatorial therapies of Alzheimer's disease, Alzheimer's disease related disorders, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, Huntington's disease, neuropathic pain, alcoholic neuropathy, alcoholism or alcohol withdrawal, or spinal cord injury, based on baclofen and acamprosate combination.

We claim: 
     
         1 . A composition comprising (i) baclofen, (ii) acamprosate, and (iii) idalopirdine, or pharmaceutically acceptable salts, derivatives or prodrugs thereof. 
     
     
         2 . The composition of  claim 1 , wherein the compounds are in admixture with a pharmaceutically acceptable carrier or excipient. 
     
     
         3 . The composition of  claim 1 , which comprises a dose of baclofen of less than 150 mg. 
     
     
         4 . The composition of  claim 1 , which comprises a dose of acamprosate of less than 1000 mg. 
     
     
         5 . The composition of  claim 1 , which comprises a dose between 0.4 mg and 50 mg of acamprosate and between 6 and 15 mg of baclofen. 
     
     
         6 . The composition of  claim 1 , which comprises baclofen, acamprosate and idalopirdine as the only active agents. 
     
     
         7 . The composition of  claim 1 , which is a solid formulation suitable for oral administration. 
     
     
         8 . A method for treating Alzheimer in a human subject in need thereof, comprising administering to said subject and effective amount of baclofen, acamprosate and idalopirdine, or pharmaceutical acceptable salt(s) or derivative(s) thereof. 
     
     
         9 . The method of  claim 8 , wherein the compounds are in admixture with a pharmaceutically acceptable carrier or excipient. 
     
     
         10 . The method of  claim 8 , wherein baclofen, or the pharmaceutically acceptable salt or derivative thereof, is administered at a dose of less than 150 mg. 
     
     
         11 . The method of  claim 8 , wherein acamprosate, or the pharmaceutically acceptable salt or derivative thereof, is administered at a dose of less than 1000 mg. 
     
     
         12 . The method of  claim 8 , wherein acamprosate, or the pharmaceutically acceptable salt or derivative thereof, is administered at a dose between 0.4 mg and 50 mg, and baclofen, or the pharmaceutically acceptable salt or derivative thereof, is administered at a dose between 6 mg and 15 mg, twice daily. 
     
     
         13 . The method of  claim 8 , wherein baclofen, acamprosate and idalopirdine, or the pharmaceutically acceptable salt(s) or derivative(s) thereof, are the only agents administered for treating Alzheimer disease. 
     
     
         14 . The method of  claim 8 , wherein baclofen, acamprosate and idalopirdine, or the pharmaceutically acceptable salt(s) or derivative(s) thereof, are formulated or administered together, separately or sequentially. 
     
     
         15 . The method of  claim 8 , wherein baclofen, acamprosate and idalopirdine, or the pharmaceutically acceptable salt(s) or derivative(s) thereof, are administered orally.